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临床试验/CTRI/2025/09/094246
CTRI/2025/09/094246
尚未招募
3 期

Comparison of pre-procedural ultrasound assisted modified paramedian technique versus ultrasound assisted midline technique on successful dural puncture on first attempt in patients undergoing surgeries under spinal anesthesia - A Randomized Controlled Trial.

Pondicherry Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年9月14日最近更新:

概览

阶段
3 期
状态
尚未招募
入组人数
108
试验地点
1
主要终点
Primary objective: To compare the rate of successful dural puncture on the first needle insertion attempt between pre procedural ultrasound assisted modified paramedian technique and pre procedural ultrasound assisted midline techniques in patients undergoing surgeries under spinal anesthesia.

概览

简要总结

This is a randomized controlled trial done at Pondicherry Institute of Medical Sciences which will compare pre-procedural ultrasound-assisted midline and modified paramedian techniques (0.5 cm & 1 cm lateral) for spinal anesthesia in 108 adult surgical patients. Primary outcome is first-attempt dural puncture success; secondary outcomes include number of passes, LFD visibility, anatomical distances, and complications. The study hypothesizes that modified paramedian approaches will yield higher first-attempt success rates, fewer needle manipulations, and reduced patient discomfort compared to the midline technique.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients belonging to American society of Anesthesiologist physical status classification (ASA- PS -I, II & III)
  • Patients scheduled for elective surgeries under spinal anesthesia.

排除标准

  • 未提供

结局指标

主要结局

Primary objective: To compare the rate of successful dural puncture on the first needle insertion attempt between pre procedural ultrasound assisted modified paramedian technique and pre procedural ultrasound assisted midline techniques in patients undergoing surgeries under spinal anesthesia.

时间窗: out come would be assessed immediately after the procedure

次要结局

  • To compare the following parameters between the two groups:(1. Number of needle insertion attempts)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Bannur Manisha

Pondicherry Institute of Medical Sciences

研究点 (1)

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